Medical Device Manufacturer · US , St.Louis , MO

Bioclinical Systems, Inc.

13 submissions · 13 cleared · Since 1985
13
Total
13
Cleared
0
Denied

Bioclinical Systems, Inc. — FDA 510(k) Submissions

Bioclinical Systems, Inc. has submitted 13 FDA 510(k) premarket notifications since 1985, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Culture Media, For Isolation Of Pathogenic Neisseria, Radioimmunoassay, Luteinizing Hormone, Glucose Oxidase, Glucose, Tetraphenyl Borate, Colorimetry, Potassium, Visual, Pregnancy Hcg, Prescription Use . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
K950196 · JTY Culture Media, For... · Microbiology
Jun 1995 163d
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
K945911 · JTZ Culture Media,... · Microbiology
Apr 1995 123d
MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR
K933122 · JTY Culture Media, For... · Microbiology
Feb 1994 229d
MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
K933121 · JTY Culture Media, For... · Microbiology
Feb 1994 223d
ROUND 1
K873086 · JXA Kit, Screening, Urine · Microbiology
Aug 1987 18d
MICRO-ELISA HLH TEST KIT MONOCLONAL
K860333 · CEP Radioimmunoassay,... · Chemistry
Apr 1986 82d
VISI-CHECK HLH TEST MONOCLONAL
K860334 · CEP Radioimmunoassay,... · Chemistry
Apr 1986 82d
MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
K855227 · KLS Enzyme Immunoassay,... · Toxicology
Apr 1986 102d
MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
K854059 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jan 1986 102d
MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT
K854379 · JLW Radioimmunoassay,... · Chemistry
Jan 1986 69d
NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
K850079 · LCX Kit, Test, Pregnancy,... · Chemistry
Mar 1985 54d
BCS GLUCOSE COLORIMETRIC TEST
K850257 · CGA Glucose Oxidase, Glucose · Chemistry
Mar 1985 42d
BCS POTASSIUM TURBIDIMETRIC TEST
K850258 · CEJ Tetraphenyl Borate,... · Chemistry
Feb 1985 16d
Filters